Portex 101/810/090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517077032), received between Mar 3, 2026 and Mar 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE PLASTIC THAT HOLDS PATIENT'S "NECKTIE" IN PLACE HAD SNAPPED CAUSING THE TRACHEOSTOMY TO COME LOOSE. THE TRACHEOSTOMY BROKE AT THE SITE WHERE THE FABRIC NECKTIE WRAPS AROUND THE SOFT PLASTIC OF THE BASE PLATE OF THE FLANGE. THE BROKEN TRACHEOSTOMY WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24502377 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE PLASTIC THAT HOLDS PATIENT'S "NECK TIE" IN PLACE HAD SNAPPED CAUSING THE TRACHEOSTOMY TO COME LOOSE. THE TRACHEOSTOMY BROKE AT THE SITE WHERE THE FABRIC NECK TIE WRAPS AROUND THE SOFT PLASTIC OF THE BASE PLATE OF THE FLANGE. THE BROKEN TRACHEOSTOMY WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24502129 ↗